Because audio, video or digital recordings include images or voices of research participants, they pose a greater concern to the IRB than do data that do not have readily available identifying information. Therefore, to best protect research participants, the IRB requires that any such recordings be destroyed within a definitive timeframe (e.g., five years following the making of the recordings, five years after data are collected).

Although recordings are not specifically addressed in 45 CFR 46, the consent process is clearly defined and holding recordings indefinitely and/or for an unspecified purpose challenges the spirit of informed consent and has the potential to increase risk to participants (e.g., breach of confidentiality, damage to reputation, legal ramifications). To be in line with informed consent and to minimize risk, participants must be informed (in the informed consent form) about the destruction timeframe, as well as informed about who will have access to the recordings and where they will be stored.

PLEASE NOTE: Exceptional circumstances will be considered on a case-by-case basis to determine whether these guidelines should or should not apply.

Archiving Recordings for Future Research

Because the IRB recognizes the potential value in archiving recordings for future research, if an investigator wishes to archive recordings, the IRB requires the following information to consider the request:

Included in the application must be sound justification for archiving recordings indefinitely.

The informed consent form must include the following:

A statement indicating where and how recordings will be stored, secured.

A statement indicating who will have access to recordings.

Space for participants to indicate whether they

Want recordings to be destroyed by the timeframe specified, or

Permit the recordings to be archived for future research within a given research area (e.g., language development, spatial perception, conversational attributes).

PLEASE NOTE: The application may need to be reviewed at the Full Board Review level, allowing the IRB to decide collectively whether or not archiving the recordings increases risk to participants. The time required for full reviews is tied to IRB meeting dates. Please see meeting dates and submission deadlines and plan accordingly.

Using Archived Recordings for Secondary Data Analysis

Any proposed use of already-archived recordings (i.e., secondary data analysis) must be reviewed by the IRB. A copy of the informed consent form from the original study must be submitted with the protocol application.

If the IRB finds that the purpose of the secondary data analysis is related to the purpose of the original study and the material in the recordings does not put the participant at risk, the application for secondary data analysis is likely to undergo an Expedited Review.

If the purpose of the secondary data analysis is found to differ significantly from the purpose of the original study or the material in the recordings could put the participants at risk, the application for secondary data analysis is likely to undergo a Full Board Review. The Full Board IRB will determine whether or not secondary analysis of the recordings increases risk to participants and whether or not participants were adequately informed during the original study about the use, confidentiality, and destruction of their recordings. Based on these findings, the IRB may require that informed consent for secondary analysis is obtained from participants.

Use of Research Recordings for Educational Purposes or Presentation Purposes

The use of these segments must be clearly defined in the informed consent form and participants must have the option of whether or not they consent to such uses of the recordings. For example:

______I agree that segments of the recordings made of my participation in this research may be used for conference presentations.
______I do not want segments of the recordings made of my participation in this research to be used for conference presentations.
______I agree that segments of the recordings made of my participation in this research may be used for education and training of future researchers/practitioners.
______I do not want segments of the recordings made of my participation in this research to be used for education and training of future researchers/practitioners.

Once segments have been chosen, the remainder of the recordings must be destroyed (unless approved for archiving). Segments cannot be used for purposes beyond those detailed and consented to in the informed consent form.